regulatory
confidence high
sentiment positive
materiality 0.80
Armata gets FDA Breakthrough Therapy designation for AP-SA02 in S. aureus bacteremia
Armata Pharmaceuticals, Inc.
- FDA granted Breakthrough Therapy designation to AP-SA02 for adjunct treatment of complicated bacteremia caused by MSSA or MRSA.
- Designation based on Phase 1b/2a diSArm data: 100% of AP-SA02 patients maintained clinical response vs 75% on placebo at day 28.
- AP-SA02 dosing every 6h for 5 days was well tolerated; no serious adverse events attributed to the drug.
- AP-SA02 now holds Breakthrough Therapy, Fast Track, and QIDP designations from the FDA.
- CEO Deborah Birx cites potential to become first antibacterial approved on superiority to standard of care.